Cleared Traditional

K882052 - OMEGA NV(TM) BALLOON DILATATION CATHETER

K882052 is the FDA 510(k) clearance for OMEGA NV(TM) BALLOON DILATATION CATHETER by Cook, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K882052 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
121d
Days
Class 2
Risk

K882052 is an FDA 510(k) clearance for the OMEGA NV(TM) BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 14, 1988 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

Submission Details

510(k) Number K882052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1988
Decision Date September 14, 1988
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K882052.
USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP
K890325 · C.R. Bard, Inc. · Mar 1989
STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR
K885247 · Baxter Healthcare Corp · Mar 1989
ACS SCHWARTEN XT BALLOON DILATATION CATHETER
K882925 · Advanced Cardiovascular Systems, Inc. · Sep 1988
CORDIS PTA DILATATION CATHETERS
K880612 · Cordis Corp. · Jul 1988
PERIPHERAL DILATATION CATHETER
K880298 · Medi-Tech, Inc. · Apr 1988
SCIMED INFLATION DEVICE, MODEL SM 2000
K875064 · Scimed Life Systems, Inc. · Feb 1988